This clinical trial describes the use of FGN-1, the sulfone metabolite of the non-steroidal anti-inflammatory drug sulindac in a randomized double-blind, placebo-controlled, multicenter, 12 month study of men with recurrent prostate cancer after radical prostatectomy. FGN-1 lacks cyclo-oxygenase inhibitory activity and presumably the gastrointestinal and renal side effects of sulindac.